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Title A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations
Therapeutic Area Leukemias (Pediatric)
Principal Investigator Jason Law, MD
Min Age 0 Years
Max Age 22 Years
Gender Male and Female
Contact NCCCR
More Information


This is a randomized Phase 3 trial that will compare efficacy of CPX-351 during Induction 1 and Induction 2 versus standard chemotherapy for children with do novo, non FLT3-mutant AML.

Study Details

Inclusion Criteria

  • All patients must be enrolled on APEC14B1 and consented to Eligibility Screening prior to enrollment and treatment on AAML183
  • Patients must be less than 22 years of age at the time of study enrollment
  • Patient must be newly diagnosed with de novo AML according to the 2016 WHO classification with or without extramedullary disease

Exclusion Criteria

  • Patients with the following constitutional conditions are not eligible: myeloid neoplasms with germline predisposition are not eligible, fanconi anemia, shwachman diamond syndrome, trisomy 21, any other known bone marrow failure syndrome
  • Patients with any fo the following oncologic diagnoses are not eligible: any concurrent malignancy, JMML, Philadelphia chromosome positive AML, mixed phenotype acute leukemia, acute myeloid leukemia arising from myelodysplasia, therapy-related myeloid neoplasms
  • Admisitration of prior anti-cancer therapy except as outlined: hydroxyurea, ATRA, corticosteroids, intrathecal therapy given at diagnosis

Study Requirements

 Upon patient consent, additional bone marrow and peripheral blood will be collected for banking at the following timepoints:


  • End of Induction 1
  • End of Induction 2
  • End of Intensification 1

  • End of Intensification 2 (if applicable)

  • End of Intensification 3 (if applicable)

  • Between Day 15 and Day 100 after stem cell transplant (if applicable, 1 sample in this timeframe)

  • Relapse

Additionally, peripheral blood samples for cardiac biomarkers may be collected at the following timepoints:
  • Baseline

  • Induction 1 day 8

  • End of induction 1

  • End of induction 2

  • End of intensification 1

  • Intensification 2 day 8

  • End of intensification 2

  • End of intensification 3

  • Prior to the start of maintenance

  • Week 26 of maintenance

  • End of therapy